Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome

NCT00977171 | Terminated Phase 2 Results

• 1 other identifier: Droxidopa CFS201
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not precisely understood, a dysfunction of the autonomic nervous system is thought to play a role in this subset of patients. In several small studies, subjects within this subset have noted improvement in their chronic fatigue symptoms when treated for their neurally mediated hypotension. As droxidopa acts on the autonomic nervous system and has been shown to ameliorate symptoms of neurally mediated hypotension, it is hypothesized that droxidopa could aid in the treatment of chronic fatigue symptoms. Neurally mediated hypotension has been associated with patients suffering from chronic fatigue syndrome. Droxidopa meanwhile has been approved in Japan for the treatment of the symptoms of neurogenic orthostatic hypotension. As such, it is hypothesized that regulating the autonomic nervous system in patients with Chronic fatigue syndrome may prove to be clinically beneficial.

Conditions

Chronic Fatigue Syndrome; Orthostatic Hypotension; Neurally Mediated Hypotension; Neurogenic Orthostatic Hypotension

Keywords

chronic fatigue syndrome; CFS; neurally mediated hypotension; NMH; neurogenic orthostatic hypotension; NOH; orthostatic hypotension; droxidopa

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Improvement

  The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.

  Baseline to end of 12 week treatment period

Study Arms (1)

Droxidopa

EXPERIMENTAL

Drug: Droxidopa

Interventions

Droxidopa DRUG

Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period

Also known as: L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, L-DOPS

Droxidopa

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Taking a direct acting vasoconstricting agent (i.e. ephedrine or midodrine)
• \- Patients taking vasoconstrictor agents such as ephedrine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2);
• Taking anti-hypertensive medication for the treatment of high blood pressure
• Women of childbearing potential who are not using a medically accepted contraception;
• Subject Restrictions: Reproductive potential: Female subjects should be either post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) who are using or agree to use acceptable methods of contraception throughout the study period and for 4 weeks after the last dose of investigational product. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. If hormonal contraceptives are used they should be taken according to the package insert. WOCP who are not currently sexually active must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of the study and for 4 weeks after the last dose of investigational product.
• For WOCP a urine pregnancy test must be conducted at screening, baseline and study termination; the results must be negative at screening and at baseline. Any positive result will be confirmed by serum beta HCG pregnancy test.
• Sexually active males whose partner is a WOCP must agree to use condoms for the duration of the study and for 4 weeks after the last dose;
• Women who are pregnant, breast feeding, or plan to become pregnant during the course of this study;
• Have a history of closed angle glaucoma;
• Have uncontrolled supine hypertension, defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>110 mmHg or use of ≥2 antihypertensive medications;
• Have atrial fibrillation or, in the investigator's opinion, have any other significant cardiac arrhythmia;
• Current melancholic major depressive disorder, or a previous diagnosis of psychosis, eating disorder, or bipolar disorder.
• History of substance abuse or dependence within the past two years, excluding nicotine and caffeine.
• Have a history of more than moderate alcohol consumption; (drinking in moderation is defined as having no more than 1 drink per day for women and no more than 2 drinks per day for men. This definition is referring to the amount consumed on any single day and is not intended as an average over several days)
• Known or suspected hypersensitivity to the study medication or any of its ingredients;

Sponsors & Collaborators

• Chelsea Therapeutics: lead

Study Sites (1)

7421 Carmel Executive Park Drive, Ste. 320

Charlotte, North Carolina, 28226, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Hypotension, Orthostatic

Interventions

Droxidopa; 3,4-dihydroxyphenylserine aldolase

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Norepinephrine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Chelsea Therapeutics Inc.

hewitt@chelsearx.com

704-973-4202

Study Officials

• Charles W Lapp, M.D.

  Hunter-Hopkins Center, P.A.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 15, 2009
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

US (1)