Effects of L-DOPS in Patients with Low- and Normal- Blood Pressure Variants of Orthostatic Intolerance.

Phase 2

Completed

• Conditions: Orthostatic Intolerance; Vasovagal Syncope; Neurological - Other neurological disorders; Neurally Mediated Syncope; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12612000157875
• Lead Sponsor: BakerIDI Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-03
• Study Completion: 2014-08-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

Participants with Orthostatic Intolerance

1.Age 18-50

2.Clinical disorder of orthostatic intolerance in association with syncope or recurrent presyncope.

a.An underlying medical condition causing these symptoms has been excluded, in particular structural heart disease, Addison’s disease and hypothyroidism.
b.Symptoms will have been present and occurring at least weekly for > or = 6 months. Symptoms include lightheadedness, weakness, blurred vision, syncope or presyncope.

3.Clinical Phenotype consistent with either Low- or Normal- Supine BP Vasovagal syncope;
a.Low- Supine Blood Pressure is defined as a typical (two or more BP readings by a medical practitioner) supine blood pressure of < or= 100 mmHg
b.Normal-Supine Blood Pressure is defined as a typical supine blood pressure of > or = 110 and < or = 140 mmHg

Healthy Control Participants for Basline comparison only ( no drug phase):

Aged between 18- 50 years.
No history of fainting or symptoms such as light-headedness, blurred vision, nausea or palpitations in association with standing.

Exclusion Criteria

Participants with Orthostatic Intolerance:
1.Age <18 or > 50
2.Pregnant or Breastfeeding women
3.Women of childbearing potential who are not using medically accepted contraception;
Reproductive potential: Female subjects should be either postmenopausal
(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. 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.

4.Sexually active males whose partner is a WOCP and who do not agree to use
condoms for the duration of the study and for 30 days after the last dose;

5.Inability to withhold pressor medications for the duration of the study. Pressor medications, (eg Fludrocortisone, Midodrine, Dihydroergotamine, Pseudoephedrine, Licorice Extract, Butcher’s Broom, Cold and Flu remedies, Diet pills, NSAIDs, pyridostigmine) must be ceased for 2 weeks prior to the commencement of the study and withheld for the entire duration of the study.

6.Antidepressant medications including: tricyclics and tetracyclic antidepressants, SSRI/ SNRI/ NRI’s, MAO inhibitors;

7. Medications known to lower blood pressure that cannot be withheld for the duration of the study, eg beta -blockers;

8.Presence of structural heart disease – including ischaemic heart disease.

9.Hypertension (supine SBP > or =140 mmHg)

10.Diabetes

11.Gastrointestinal illness that may impair absorption of the study drug.

12.Known or suspected hypersensitivity to the study medication or any of its ingredients;

13.In the investigator’s opinion, have clinically significant abnormalities on clinical examination or laboratory testing;

Healthy Control Participants:
Age<18 or >50 years
Necessary Medication other than the oral controaceptive pill
Pregnant or Breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified