Trial record 14 of 43 for:    Open Studies | "Anorexia Nervosa"

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

This study is currently recruiting participants.
Verified March 2014 by Rhythm Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01642550
First received: July 13, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Anorexia Nervosa
Drug: RM-131
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Rhythm Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Effect of RM-131 on body weight [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change from baseline in body weight.


Secondary Outcome Measures:
  • Effect of RM-131 on gastric emptying time [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change from baseline in gastric half-emptying time (t1/2).

  • Effect of RM-131 on appetite [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change from baseline in appetite.


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RM-131 Drug: RM-131
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Placebo Comparator: Placebo Drug: RM-131
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642550

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rebecca DeSanti       rdesanti@partners.org   
Sponsors and Collaborators
Rhythm Pharmaceuticals, Inc.
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01642550     History of Changes
Other Study ID Numbers: RM-131-005
Study First Received: July 13, 2012
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rhythm Pharmaceuticals, Inc.:
Anorexia nervosa
Anorexia
Eating disorders

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

ClinicalTrials.gov processed this record on April 15, 2014