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A Double-blind, Placebo Controlled, Randomized INTerventional Clinical Trial (SARA-INT) (SARA-INT)

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ClinicalTrials.gov Identifier: NCT03452488
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Biophytis

Brief Summary:

SARA-INT is a phase 2 interventional study performed in Europe and USA aimed to evaluate the clinical benefits, safety and tolerability of the investigational drug BIO101 administered orally for a six-month (26 weeks) duration to older patients, community dwelling men and women aged ≥65 years, suffering from age-related sarcopenia (including sarcopenic obesity), and at risk of mobility disability.

The double-blind, placebo controlled clinical trial will collect and analyse data on physical performance and body composition and will specifically focus on the change of one functional measurement, the gait speed measured during the 400MW test plus the change of a highly standardised patient reported outcome (PRO), the physical function domain PF-10 at the SF-36 auto-evaluation questionnaire, in order to estimate the efficacy of BIO101 administered over 26 weeks, in preventing mobility disability in the target population.


Condition or disease Intervention/treatment Phase
Sarcopenia Drug: BIO101 Drug: Placebo oral capsule Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Investigator)
Masking Description: Each treatment kit will show a preprinted kit number affixed on the primary, secondary and tertiary container. The kit number will be assigned via the eCRF after a patient is qualified and is randomised. Nor the Investigator and his staff, either the Sponsor will be aware of the treatment that corresponds to the kit number. The assigned treatment cannot be retrieved from the system, unless a specific unblinding procedure is engaged by the investigator when this is judged necessary by the responsible physician of the investigator center in the context of a severe or serious adverse event.
Primary Purpose: Treatment
Official Title: Safety and Efficacy of BIO-101 Oral Administration to Patients Suffering From Age-related SARcopenia, Including Sarcopenic Obesity, Aged ≥65 Years and at Risk of Mobility Disability (SARA-INT)
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Placebo Comparator: Arm 1 - Placebo oral capsule

4 capsules taken twice a day: in the morning and in the evening with the meal approximately at 12-hour distance for 26 weeks.

Component : Microcrystalline cellulose, Colloidal anhydrous silica

Drug: Placebo oral capsule
Oral capsules containing Microcrystalline cellulose, Colloidal anhydrous silica

Experimental: Arm 2 - BIO101 - Half daily dose 350 mg

4 capsules taken twice a day (2 placebo and 2 experimental study drug) in the morning and in the evening with the meal approximately at 12-hour distance for 26 weeks.

Study Drug Component : 251 mg per capsule including 175 mg of active principle 20-hydroxyecdysone (20E) containing also the following compendial excipients: colloidal silica, microcrystalline cellulose and magnesium stearate.

Drug: BIO101
Oral capsules containing the BIO101 active principle is 20-hydroxyecdysone (20E), which is found and extracted by purification from the edible plant Stemmacantha carthamoides Component : 251 mg per capsule including 175 mg of active principle 20E containing also the following compendial excipients: colloidal silica, microcrystalline cellulose and magnesium stearate.

Drug: Placebo oral capsule
Oral capsules containing Microcrystalline cellulose, Colloidal anhydrous silica

Experimental: Arm 3 - BIO101 - Full daily dose 700 mg

4 capsules taken twice a day (4 experimental study drug) in the morning and in the evening with the meal approximately at 12-hour distance for 26 weeks.

Study Drug Component : 251 mg per capsule including 175 mg of active principle 20E containing also the following compendial excipients: colloidal silica, microcrystalline cellulose and magnesium stearate.

Drug: BIO101
Oral capsules containing the BIO101 active principle is 20-hydroxyecdysone (20E), which is found and extracted by purification from the edible plant Stemmacantha carthamoides Component : 251 mg per capsule including 175 mg of active principle 20E containing also the following compendial excipients: colloidal silica, microcrystalline cellulose and magnesium stearate.




Primary Outcome Measures :
  1. Gait speed measured during the 400MW test. [ Time Frame: The change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo). ]
    The 400MWT is a measure of how long it takes a participant to walk a distance of 400 m. it is express in m/s


Secondary Outcome Measures :
  1. PF-10 subscore of the SF-36 [ Time Frame: The change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo) ]

    Electronically self administrated or filling a paper booklet Patient Reported Outcome SF-36 will be assessed through a SF-36 questionnaire.

    The physical function score (PF-10), role limitations due to physical problems.


  2. Appendicular Lean Body Mass [ Time Frame: The change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo) ]
    Body composition especially Lean Body Mass in kg measured using DEXA. This will allow definition of the appendicular Lean Body mass

  3. Body Fat Mass [ Time Frame: The change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo) ]
    Body composition especially Fat Mass will be measured in kg. This will allow definition of the body Fat mass

  4. 400MW test rate of success to complete the test [ Time Frame: The change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo) ]
    The 400MW rate of success is the ability to complete the test at all (yes/no).

  5. handgrip test [ Time Frame: Change from Baseline Grip Strength to measurement at 6 months ]
    The grip strength will be measured using the appropriate dynamometer. Strength in kg will be measured 3 times for both hands and the highest value will be kept for further analysis.

  6. Knee extension test [ Time Frame: Change from Baseline Knee extension to measurement at 6 months ]
    The knee extension in kg measurement will be performed using isokinetic dynamometer.

  7. Stair Climb Power Test [ Time Frame: Change from Baseline Stair Climb Power Test to measurement at 6 months ]
    The ability to ascend and descend stairs (9 stairs of 20 cm height) will be assessed in a specific period of time

  8. SPPB [ Time Frame: Change from Baseline SPPB to measurement at 6 months ]
    Physical performance tests corresponding to standing balance, walking speed and chair stand will be assessed

  9. Patient Reported Outcomes : SarQoL: Sarcopenia Quality of Life [ Time Frame: The change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo) ]
    Electronically self administrated or filling a paper booklet Patient Reported Outcome SarQoL will be assessed through the SarQoL. The SarQoL® is composed of 22 questions including in total 55 items rated on a 4-point Likert scale. The questionnaire is scored, through a scoring algorithm, on 100 points, with higher scores reflecting a better quality of life.


Other Outcome Measures:
  1. Biomarkers [ Time Frame: Change from Baseline Biomarkers to measurement at 6 months ]
    Biomarkers specific to Sarcopenia, to the Renin Angiotensin System

  2. Actimetry [ Time Frame: Change from actimetry at Month 0 to measurement at 6 months ]
    The continuous physical activity of the volunteers will be recorded using a specific device during the 6-month study period.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged ≥ 65 years and living in the community, reporting loss of physical function over the last 6-12 months
  4. Short Physical Performance Battery (SPPB) score ≤ 8
  5. ALM/BMI < 0.789 in men and 0.512 in women, or ALM < 19.75kg in men and <15.02kg in women, as measured by DEXA scan
  6. Ability to take oral medication and be willing to adhere to the study intervention regimen.
  7. Agreement to adhere to Lifestyle Considerations throughout study duration
  8. In the US, women and members of minority groups must be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants In Research Involving Human Subjects.

Exclusion Criteria:

  1. Current use of anabolic drugs e.g. testosterone; current use of Erythropoietin; current use of corticosteroid agents (except local administration route, like eye drops or dermatologic formulations)
  2. Non-menopausal women (however ongoing replacement hormonal treatment is not an exclusion criterion)
  3. Known allergic reactions to components of the investigational drug (i.e. stemmacantha carthamoides leaves and roots).
  4. Febrile illness within 7 days
  5. Treatment with another investigational drug or other intervention within three months
  6. Unable to understand and perform the functional tests, as judged by the Investigator
  7. Inability to perform the 400MW test within 15 minutes
  8. Clinical conditions:

    1. Current diagnosis of major psychiatric disorders.
    2. Alcohol abuse or dependence
    3. Severe arthritis
    4. Cancer requiring active treatment (cancer treated with chemotherapy, or radiotherapy and currently on remission is not an exclusion criterion)
    5. Lung disease requiring regular use of supplemental oxygen
    6. Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents
    7. Severe cardiovascular disease (including New York Heart Association [NYHA] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
    8. Parkinson's disease or other progressive neurological disorder
    9. Renal disease requiring dialysis, or known renal insufficiency (moderate or severe reduction in GFR≤30 ml/min/1.73 m2)
    10. Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline functional tests 400-meter walk test or 6MWT
    11. History or active signs or symptoms of gallbladder/biliary disease (e.g. previous episodes of cholestasis/biliary tract obstruction, cholelithiasis, cholecystitis, etc.). Of note, history of cholecystectomy and no active biliary signs or symptoms, is not an exclusion criterion.
  9. Current physical/rehabilitation therapy (except for passive physical therapy. However, this should not be initiated the week before an evaluation visit and once started, it should be maintained over the study duration).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452488


Contacts
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Contact: Samuel Agus, MD 33144272338 Samuel.Agus@biophytis.com
Contact: Waly Dioh, PhD 33144272339 waly.dioh@biophytis.com

Locations
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United States, Florida
Institut On Aging Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Marco Pahor, Pr         
Contact: Annie Allen         
United States, Massachusetts
Jean Mayer USDA Human Nutrition research Center on Aging Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Roger A Fielding, Pr         
Contact: Sarah White         
United States, North Carolina
Bowman Gray Center for Medical Education-of- Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27101
Contact: Stephan Kritchevsky, Dr         
United States, Texas
Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Denis Villareal, Dr         
Belgium
Vrije Universiteit Brussel Recruiting
Bruxelles, Belgium, 1090
Contact: Ivan Bautmans, Pr         
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Centrum voor metabole botziekten Not yet recruiting
Leuven, Belgium, 3000
Contact: Evelien Gielen, Dr         
Université de Liège Recruiting
Liège, Belgium, 4020
Contact: Olivier Bruyere, PhD         
Contact: Médéa Locquet, Ph         
France
Hôpital Broca Département de Gerontologie Not yet recruiting
Paris, France, 75005
Contact: Olivier Hanon, Pr         
Gérontopole Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Yves Rolland         
Contact: Emilie Durand         
Italy
IRCCS University-Ospedale San Martino Not yet recruiting
Genova, Italy, 16132
Contact: Samir Sukkar, Pr         
University of Padova Not yet recruiting
Padova, Italy, 35128
Contact: Giuseppe Sergi, Pr         
Policlinico Universitario Campus Biomedico Not yet recruiting
Roma, Italy, 00128
Contact: Raffaele Antonelli-Incalzi, Pr    (+39) 06.22541.653      
Sapienza University of Rome Policlinico Umberto1 Not yet recruiting
Roma, Italy, 00185
Contact: Maurizio Muscaritoli, Pr         
Sapienza University of Rome Not yet recruiting
Roma, Italy, 00185
Contact: Lorenzo Donini, Pr         
Sponsors and Collaborators
Biophytis
Investigators
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Study Director: Samuel Agus, MD Biophytis

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Responsible Party: Biophytis
ClinicalTrials.gov Identifier: NCT03452488     History of Changes
Other Study ID Numbers: BIO101-CL03
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biophytis:
Sarcopenia
Sarcopenic Obesity
6-minute walking distance
400 meters walking test
Patient Reported Outcomes
BIO101
SPPB
ALM; ALM/BMI

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms