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Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00532532
Recruitment Status : Terminated
First Posted : September 20, 2007
Last Update Posted : November 4, 2008
Sponsor:
Information provided by:
Avigen

Brief Summary:

A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes:

  1. To determine whether AV650 is safe for patients with multiple sclerosis;
  2. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,
  3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).

Condition or disease Intervention/treatment Phase
Muscle Spasticity Drug: tolperisone HCl Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis
Study Start Date : September 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
AV650 low dose
Drug: tolperisone HCl
Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

Experimental: 2
AV650 high dose
Drug: tolperisone HCl
High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

Experimental: 3
Placebo
Drug: tolperisone HCl
Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks




Primary Outcome Measures :
  1. To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS [ Time Frame: 38 weeks ]

Secondary Outcome Measures :
  1. To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS; and to determine the pharmacokinetic (PK) profile of AV650 at two dose levels [ Time Frame: 38 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between 18 and 70 years of age (inclusive)
  • Signed and dated informed consent
  • Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course)
  • Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening
  • Stable MS for at least 30 days before screening
  • Female of child bearing potential and male subjects whose partner is of child bearing potential who are willing to ensure that they or their partner use effective double-barrier contraception during the study and for 90 days thereafter
  • If female, be neither pregnant nor nursing (Confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test at baseline.)
  • Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group
  • If a subject is on anti-spastic treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
  • If a subject is on MS treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening

Exclusion Criteria:

  • Subjects who have participated in another research study within 90 days of Screening
  • Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening
  • Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products
  • Use of tolperisone HCl within 30 days of screening
  • Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening
  • Spasticity due to neurological disorders other than MS
  • Any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study
  • Subjects who have suffered an acute relapse of MS or who continue to suffer from an acute relapse of MS within 90 days of Baseline
  • History of alcohol or substance abuse within one year of Screening
  • Concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than MS
  • Clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction
  • QT prolongation greater than 480 msec or greater than 450 msec if accompanied by a partial bundle branch block, or other ECG abnormality in the judgment of the Investigator
  • Diastolic blood pressure <50mmHg or >105mmHg; heart rate <50 beats per minute (bpm) or >110bpm, after 3 minutes in a sitting position; heart rate by ECG <50bpm or >110bpm
  • History of epilepsy (except childhood febrile seizures)
  • Current malignancy or history of malignancy that has not been in remission for more than five years, except basal cell skin carcinoma and cervical cancer (with treatment)
  • Female subject who is pregnant, nursing, or planning pregnancy during the course of the study
  • Scheduled elective surgery or other procedures requiring general anesthesia during the study
  • Subject who is terminally ill in the judgment of the Investigator
  • Subject who is inappropriate for placebo medication in the judgment of the Investigator
  • Systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma
  • Exacerbation of MS within 30 days of Baseline
  • Regular levo-dopa therapy within 7 days of randomization
  • Subjects taking antiarrhythmic medications
  • Donation of blood during the study

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): NCT00532532


Locations
Show Show 28 study locations
Sponsors and Collaborators
Avigen
Investigators
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Study Director: Glenn Morrison, MSc, PhD Avigen, Inc.

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Responsible Party: Glenn Morrison, Ph.D., Avigen, Inc.
ClinicalTrials.gov Identifier: NCT00532532    
Other Study ID Numbers: AV650-018
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: November 4, 2008
Last Verified: November 2008
Keywords provided by Avigen:
Multiple sclerosis
Additional relevant MeSH terms:
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Muscle Spasticity
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Tolperisone
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents