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Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT01642550
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: RM-131 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
Study Start Date : November 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015
Arms and Interventions

Arm Intervention/treatment
Active Comparator: RM-131
Active study drug - RM-131
Drug: RM-131
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Effect of RM-131 on body weight [ Time Frame: Baseline and Day 28 ]
    Change from baseline in body weight.


Secondary Outcome Measures :
  1. Effect of RM-131 on gastric emptying time [ Time Frame: Baseline and Day 28 ]
    Change from baseline in gastric half-emptying time (t1/2).

  2. Effect of RM-131 on appetite [ Time Frame: Baseline and Day 28 ]
    Change from baseline in appetite.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV criteria for anorexia nervosa, including weight <85% of ideal body weight (IBW) and amenorrhea for three months;
  • Age 18-45 years old;
  • Gastrointestinal tract symptoms;
  • Non-hormonal method of birth control, which must be used throughout the study. Female patients unable to bear children must have this documented (i.e., tubal ligation, hysterectomy, or post-menopausal, defined as a minimum of one year since the last menstrual period and elevated FSH);
  • Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline;
  • Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures, including daily SC injections and completion of a daily injection log.
  • Patient has a primary care physician or treatment team managing her care.

Exclusion Criteria:

  • Use of hormone therapy (including but not limited to estrogen, progesterone) or hormonal methods of birth control (i.e., oral, implantable, or injectable) within eight weeks of screening; or Depo-Provera within six months of screening;
  • Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening;
  • History of diabetes mellitus;
  • History of purging behaviors greater than once monthly within the last three months;
  • Active substance abuse;
  • Use of metoclopramide, erythromycin, 5HT3 anti-emetics, or opioid medications within 2 weeks prior to baseline. [Note: these drugs should also not be used post-baseline];
  • Hematocrit < 30.0 %, hemoglobin < 10.0 g/dl, potassium < 3.0 mmol/L, fasting glucose > 100 mg/dL, creatinine > 1.5 mg/dL, AST or ALT > 1.5 times the upper limit of normal, or abnormal plasma thyroid stimulating hormone (TSH) level;
  • Currently receiving parenteral feeding or enteral feeding, or presence of a nasogastric or other enteral tube for feeding or decompression;
  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure, small or large bowel resection;
  • Clinical suspicion, in the opinion of the investigator, of active or symptomatic peptic ulcer disease, cholelithiasis, colitis, celiac sprue, or inflammatory bowel disease;
  • Active suicidal ideation;
  • Beck Depression Inventory-2 score of ≥ 29;
  • Current inpatient hospitalization;
  • Allergic or intolerant of egg, milk, wheat or algae, as these are components of the GEBT test meal;
  • Participation in a clinical study with an investigational medication or device within the 30 days prior to dosing in the present study;
  • Any other reason, which in the opinion of the Investigator, including severe renal, hepatic or cardiac disease, would confound proper interpretation of the study or expose a patient to unacceptable risk.
Contacts and Locations

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): NCT01642550


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Motus Therapeutics, Inc.
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
More Information

Responsible Party: Motus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01642550     History of Changes
Other Study ID Numbers: RM-131-005
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Motus Therapeutics, Inc.:
Anorexia nervosa
Anorexia
Eating disorders

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders