Clinical trial NCT01642550: Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Anorexia
Eating disorders
Lead sponsor: Motus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Effect of RM-131 on body weight
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: Effect of RM-131 on gastric emptying time
timeFrame: Baseline and Day 28
measure: Effect of RM-131 on appetite
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne Klibanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fazeli PK, Lawson EA, Faje AT, Eddy KT, Lee H, Fiedorek FT, Breggia A, Gaal IM, DeSanti R, Klibanski A. Treatment With a Ghrelin Agonist in Outpatient Women With Anorexia Nervosa: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11585. doi: 10.4088/JCP.17m11585.